Efficacy of the Chronic Application of Tear Formulations

NCT01384851 | Unknown DMC

• 1 other identifier: AG9965-004
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the therapeutic effect of the chronic application of eye-drops on tear evaporation rate in dry eye and normal subjects exposed to a condition of environmental stress. The effect will be studied in terms of changes in tear physiology and the inflammatory biomarkers on the ocular surface.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Tear Film Evaporation

  Tear film evaporation will be determined with a 'Servo-Med EP-Evaporimeter'. This measures the relative humidity and temperature at two sensors separated by a known distance, above the evaporative surface. The ocular surface evaporation will be calculated from measurements of fluid loss with the eyes open and closed while the subject sits with the eye covered by a modified goggle.

  Each subject will be followed for the duration of the study, an expected average of 8-9 weeks

Secondary Outcomes (4)

• Interferometry

  Each subject will be followed for the duration of the study, an expected average of 8-9 weeks

• Tear Film Osmolarity

  Each subject will be followed for the duration of the study, an expected average of 8-9 weeks

• Non-invasive tear break up time

  Each subject will be followed for the duration of the study, an expected average of 8-9 weeks

• Tear sampling and bio-marker analysis

  Each subject will be followed for the duration of the study, an expected average of 8-9 weeks

Study Arms (3)

Next Generation Emulsion

EXPERIMENTAL

Next Generation Emulsion Multi-Dose Eye Drop (9963X) is a sterile, buffered, aqueous and emulsion topical ophthalmic product formulated for the relief of ocular surface irritation and symptoms of dryness. The Next Generation Emulsion 9963X formulation is an oil-in-water aqueous emulsion intended to replenish deficient aqueous and lipid components and stabilising the tear film.

Drug: Next Generation Emulsion

Refresh Dry Eye Therapy

ACTIVE COMPARATOR

A preserved multi-dose formulation for use in treating dry eye symptomatology. The key ingredients are Castor oil, Polysorbate 80, Carbomer 1342 and Glycerin. Refresh Dry Eye Therapy® Lubricant Eye Drops contains emulsified castor oil, which enhances the natural oily superficial tear layer on the ocular surface. By stabilizing and supplementing the lipid layer, castor oil may retard evaporation of surface moisture.

Drug: Refresh Dry Eye Therapy

Refresh Contacts

ACTIVE COMPARATOR

Solution contains carboxymethylcellulose sodium (carmellose), sodium chloride, boric acid, sodium borate, potassium chloride, calcium chloride, magnesium chloride, Purite®, sodium hydroxide, and purified water. This product is registered as a CE Mark medical device. Refresh Contacts Comfort drops providing soothing relief from tired, dry eyes. Although intended for contact lens wearers, the primary indication is for relief of dry eyes as is being studied in this investigation.

Drug: Refresh Contacts

Interventions

Next Generation Emulsion DRUG

One drop both eyes 4 times daily for two weeks

Next Generation Emulsion

Refresh Dry Eye Therapy DRUG

One drop both eyes four times daily for two weeks

Refresh Dry Eye Therapy

Refresh Contacts DRUG

One drop both eyes four times daily for two weeks

Refresh Contacts

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the ages of 18 and 79 years of age.
• Must understand and be able, willing and likely to fully comply with study procedures and restrictions.

You may not qualify if:

• Active ocular allergy
• Current contact lens wear
• Any topical ophthalmic drops within 1 week of initial screening visit.
• Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of initial screening visit.
• Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days initial of screening visit.
• Known hypersensitivity to any of the agents used in testing.

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• Allergan: collaborator

Study Sites (1)

Glasgow Caledonian University

Glasgow, G4 0BA, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Alan Tomlinson, DSc PhD

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan Tomlinson, DSc PhD

CONTACT

0044 141 331; A.Tomlinson@gcu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 29, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 1, 2011

Record last verified: 2011-02

Locations

GB (1)